FDA In Brief: FDA issues 63 product-specific guidances to promote generic drug access and drug price competition

November 28, 2018

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“As part of our ongoing effort to promote drug competition and low cost generic alternatives, we’ve committed to issuing more guidance laying out the path for developing generic copies of drugs. This is especially true when it comes to complex or hard-to-copy branded medicines. Drug access is a matter of public health. The FDA’s work to support generic competition helps reduce prices, improves access to needed medicines, and benefits the health of Americans,” said FDA Commissioner Scott Gottlieb, M.D. “These efforts are having tangible benefits for patients. For example, in fiscal year 2018, the FDA approved or tentatively approved a record 971 generic drug applications. More than two-thirds of the guidance documents we’re releasing today are for products that don’t have any generic competition. By issuing recommendations on how to develop products that are therapeutically equivalent to these branded drugs, we’re making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market. This will increase patient access to high-quality, safe and affordable medicines.”

The U.S. Food and Drug Administration today announced a new set of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 63 product-specific guidances, including 22 new guidances and 41 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. With today’s batch of guidances, the FDA has issued more than 1,600 product-specific guidances since 2007.

Of the guidances issued today, four are new draft guidances and 31 are revised guidances for complex drug products, including 23 products that, to date, do not have generic competition. The majority of the revised guidances were updated to include information on data standards formatting for clinical endpoint bioequivalence studies to align with Clinical Interchange Standards Consortium standards.

The FDA believes that increased transparency on product-specific guidances gives manufacturers seeking to develop generic copies of medicines, including complex drugs, a better opportunity to efficiently allocate drug development resources. The agency aims to make sure that its policies and regulations – and scientific standards – keep pace with the evolving science around developing generic versions of these complex products so that patients have access to affordable medicines.

Addressing these challenges and promoting more generic competition to complex medicines is a key part of our Drug Competition Action Plan and our efforts to promote patient access and lower drug prices.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.